Drug factory · FDA FEI 3006370533

Alkem Laboratories Limited

Khasra No 1544, 1553, 1558, 1559 Village Thana, Tehsil Nalagarh, Baddi Solan, India

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

May 17, 2019 inspection

• Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
  Deviations from written production and process control procedures are not justified.
• Acceptance of in-process materials 21 CFR 211.160(b)(2)
  Determinations of conformance to appropriate written specifications for acceptance are deficient for in-process materials.
• Approve or reject components, products 21 CFR 211.22(a)
  The quality control unit lacks the responsibility and authority to approve and reject all drug products.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.

Registered with FDA for: analysis; manufacture; pack; repack.