Drug factory · FDA FEI 2024390

H.J. Harkins Company, Inc.

Grover Beach, California, United States

Matched to FDA's records by company name, because this plant's registration on the label has expired.

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.

Mar 3, 2023 inspection

• Lack of written stability program 21 CFR 211.166(a)
  There is no written testing program designed to assess the stability characteristics of drug products.
• Review of representative number of batches 21 CFR 211.180(e)(1)
  Written procedures are not established for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Written calibration / inspection records not kept 21 CFR 211.68(a)
  Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.

Mar 2, 2017 inspection

• Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
  Changes to written procedures are not reviewed and approved by the quality control unit.
• Strict control not exercised over labeling issued 21 CFR 211.125(a)
  Strict control is not exercised over labeling issued for use in drug product labeling operations.
• Storage under appropriate conditions 21 CFR 211.142(b)
  Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected.
• Lack of written stability program 21 CFR 211.166(a)
  There is no written testing program designed to assess the stability characteristics of drug products.
• Items to cover on annual reviews 21 CFR 211.180(e)(2)
  Written procedures are not followed for evaluations done at least annually and including provisions for a review of investigations conducted for each drug product.
• Prepared for each batch, include complete information 21 CFR 211.188
  Batch production and control records do not include complete information relating to the production and control of each batch.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• GMP Training Frequency 21 CFR 211.25(a)
  GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• Identity Testing of Each Component 21 CFR 211.84(d)(1)
  The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.

Nov 10, 2010 inspection

• Establishment of calibration procedures 21 CFR 211.160(b)(4)
  Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
• Written sanitation procedures not followed 21 CFR 211.56(b)
  Written procedures for sanitation are not followed.
• Representative Samples 21 CFR 211.84(b)
  Representative samples are not taken of each shipment of each lot of drug product containers and closures for testing or examination.