Drug factory · FDA FEI 3005430968

Zydus Lifesciences Limited

Village Swaraj Majra, P.O. Baddi, Tehsil-Nalagarh, 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 23, 2015 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
• Deviations from laboratory control requirements 21 CFR 211.160(a)
  Deviations from written test procedures and laboratory mechanisms are not recorded and justified.
• Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
  The calibration of instruments is not done at suitable intervals with provisions for remedial action in the event accuracy and/or precision limits are not met.
• Testing and release for distribution 21 CFR 211.165(a)
  Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
• Complete instructions, procedures, specifications et. al. 21 CFR 211.186(b)(9)
  Master production and control records lack complete manufacturing and control instructions.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Registered with FDA for: analysis; manufacture.