Drugs

Dr. Reddy’s Gets FDA-483 After Pre-Approval Inspection

David McFarland

— 2 min read
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FDA has issued Dr. Reddy’s a three-observation Form FDA-483 following a pre-approval inspection and Good Manufacturing Practices inspection at the company’s FTO-SEZ Process Unit-02 in Srikakulam, Andhra Pradesh, India. The inspection was conducted between 7/ 20-29, according to the company.

Dr. Reddy's said it plans to respond to the observations within the timeframe specified by the agency but did not disclose the nature of the deficiencies identified by FDA investigators.

Last month, FDA issued Dr. Reddy's a seven-observation Form FDA-483 following a recent pre-license inspection of its biologics manufacturing facility in Bachupally, Hyderabad, India. The inspection was conducted from 6/16 to 6/25 as part of FDA's review of the facility ahead of a potential product approval, the company disclosed in a filing with Indian stock exchanges.

Late last year, FDA posted a seven-item Form FDA-483 after inspecting Dr. Reddy’s Mirfield, West Yorkshire, UK, active pharmaceutical ingredient (API) manufacturing facility 9/1-5/2025. The key GMP deficiencies noted were:

  • Failure to establish adequate specifications, sampling plans, and testing procedures to ensure that raw material and APIs meet accepted quality standards and are consistent with the manufacturing process.
  • Certificates of analysis from raw material suppliers are accepted in lieu of testing each component for conformance to written specifications.
  • Failure to adequately validate written procedures for the cleaning and maintenance of equipment.
  • Written records of investigations into unexplained discrepancies do not always include the conclusion and follow-up.
  • The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
  • Document control procedures under quality unit oversight are inadequate.
  • Manually managed materials in the warehouse and facilities are not separated during storage.

In the same month, FDA released a five-item Form FDA-483 after inspecting the firm’s drug substance and drug product manufacturing facility in Telangana, India (see story). And, in December, FDA cited inspection findings at Dr. Reddy’s Srikakulam, Andhra Pradesh, India, manufacturing facility, flagging a range of quality-control, testing, and manufacturing deficiencies that could affect drug products shipped to the U.S. market.

In a seven-page Form FDA 483 issued 12/12/2025, agency investigators documented five major observations at the plant. FDA’s most extensive concerns centered on the firm’s handling of out-of-specification test results. Investigators said the company failed to thoroughly investigate unexplained discrepancies when batches failed dissolution testing and other quality specifications.

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