Drug factory · FDA FEI 3007621443
Calmo Manufacturing Inc
16601 Burke Lane, Huntington Beach, CA, United States
No problems found at FDA's last inspection, Aug 4, 2023.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2011: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Menthol, Unspecified Form and Tretinoin and Zinc Oxide | Makes it | Patchwerx Labs, Inc. | 69329-600 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 4, 2023 | No problems found | Drug Quality Assurance | — |
| Aug 23, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Apr 22, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jan 25, 2012 | No problems found | Drug Quality Assurance | — |
| May 23, 2011 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Aug 23, 2019 inspection
- Electronic records 21 CFR 11
Electronic records are used, but they do not meet retention requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records. - Lab controls established, including changes 21 CFR 211.160(a)
The establishment of laboratory control mechanisms including any changes thereto, are not reviewed and approved by the quality control unit. - 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. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Apr 22, 2016 inspection
- Annual visual exams of drug products 21 CFR 211.170(b)
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - Cleaning SOPs/instructions 21 CFR 211.67(b)(3)
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
Registered with FDA for: label; manufacture; pack.