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FDA Warning Letter to Aurobindo Pharmaceutical Limited (2022)

Last reviewed 19 Oct 2026 · 4 min read

Contents
  1. Inspection and scope of the letter
  2. Main concerns described by FDA
  3. Change evaluation for API starting materials
  4. Investigation and method-transfer controls
  5. Repeat observations and consultant recommendation
  6. Statutory provisions cited in the letter
  7. Frequently asked questions
  8. Did FDA say the warning letter listed every deficiency?
  9. Did FDA require Aurobindo to use a consultant?
  10. Did this letter establish the site’s current status?
  11. References

In short: FDA Warning Letter 320-22-10, issued on January 12, 2022, describes concerns from an August 2021 inspection of Aurobindo Pharmaceutical Limited Unit I in Telangana. The letter focuses on API change evaluation, investigation quality and method-transfer controls. This page summarizes what FDA said in that letter; it does not assess the site’s present compliance status.

Inspection and scope of the letter

FDA inspected the Unit I API manufacturing facility from August 2 to 12, 2021. The agency said its letter was not an exhaustive list of all possible deficiencies. The observations below are therefore a summary of selected issues described in the letter, not a substitute for the official notice.

Main concerns described by FDA

Change evaluation for API starting materials

FDA said the firm’s assessment of a change to an acceptance limit for an API starting material did not adequately evaluate the effect on API quality. The agency also questioned reliance on a laboratory study that included a processing step not then used in the approved commercial process, and the use of an existing related-substances method without establishing whether it could detect newly considered impurities appropriately.

The letter noted that later spike-and-purge studies were submitted, but FDA considered them inadequate to show that the change had been fully evaluated before implementation. It requested an independent assessment of the change-management system, including how changes are justified, reviewed, approved by the quality unit and checked for effectiveness.

Investigation and method-transfer controls

FDA described a failed GC-MS method-transfer result involving peak splitting. It said the investigation did not adequately consider possible equipment causes, the result was invalidated without sufficient scientific justification, and the approved transfer report did not describe the failure and corrective actions. The firm attributed the event to a deteriorated column, but FDA said the response did not establish controls to prevent recurrence or adequately address method suitability.

The letter requested an independent assessment of the investigation system and a retrospective review of specified invalidated OOS results and method transfers. FDA asked the firm to report the review’s conclusions and actions, including how it would address inconclusive laboratory investigations and potential manufacturing causes.

See also SOP on change control, SOP for failure investigation and how to investigate OOS test results, Phase I.

Repeat observations and consultant recommendation

FDA referred to similar CGMP issues discussed at a regulatory meeting on July 29, 2019, and said the repeated issues showed inadequate executive-management oversight and control. The agency strongly recommended that the firm engage a qualified consultant. It also stated that using a consultant would not transfer the firm’s responsibility for resolving the deficiencies.

Statutory provisions cited in the letter

FDA characterized the APIs as adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), codified at 21 U.S.C. § 351(a)(2)(B). The letter said FDA could refuse admission of affected articles under FD&C Act section 801(a)(3), 21 U.S.C. § 381(a)(3), if the applicable import conditions were met. It also asked the firm to contact FDA’s drug-shortage staff if a planned action was likely to disrupt supply, referring to FD&C Act section 506C(b), 21 U.S.C. § 356c(b). These are statements in the 2022 letter, not a general legal assessment.

For batch-associated GMP records within scope of applicable requirements, retain records for at least one year after the expiry date of the respective product batch. EU GMP Part I Chapter 4 §4.11 (revision 1, 2011) specifies one year after expiry or at least five years after QP certification, whichever is longer. For covered U.S. drug-product records, 21 CFR § 211.180(a) specifies at least one year after expiry, with a separate period for certain OTC products without expiry dating. Apply the rule appropriate to the product and jurisdiction.

Frequently asked questions

Did FDA say the warning letter listed every deficiency?

No. FDA stated that the observations in the letter were not intended to be an all-inclusive list.

Did FDA require Aurobindo to use a consultant?

The letter strongly recommended a qualified consultant. It also made clear that responsibility for correcting the deficiencies remained with the firm.

Did this letter establish the site’s current status?

No. It reports FDA’s findings and requests as of January 12, 2022. This summary does not establish what happened after the letter or the site’s current regulatory status.

References

  1. U.S. Food and Drug Administration. Aurobindo Pharmaceutical Limited, Warning Letter 320-22-10, MARCS-CMS 618091 (January 12, 2022). Official FDA letter.
  2. European Commission. EudraLex Volume 4, Part I, Chapter 4: Documentation, revision 1 (2011), §4.11. Official PDF.
  3. United States. 21 CFR § 211.180(a), current eCFR text (2026). Official eCFR.

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