Drug factory · FDA FEI 1721801
Manuel Enterprises, Inc. dba Nepenthe Home Medical Equipment
779 Seedling Ct, Colorado Springs, CO, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 29, 2011.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2011: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Manuel Enterprises, Inc. dba Nepenthe Home Medical Equipment | 58089-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 29, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 10 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Apr 29, 2011 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. - Written warehousing procedures established/followed 21 CFR 211.142
Procedures describing the warehousing of drug products are not established. - Signature and checking of records -- 2 persons 21 CFR 211.186(a)
The master production and control records for each batch size of drug product are not prepared, dated, and signed by one person with a full handwritten signature and independently checked, dated, and signed by a second person. - Batch production and Batch Control Record Requirements 21 CFR 211.188(b)
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in processing and packing. - Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. - 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. - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices, and written procedures required by current good manufacturing practice regulations. - Supervisor Training/Education/Experience 21 CFR 211.25(b)
Individuals responsible for supervising the manufacture, processing, packing, and holding of a drug product lack the education, training, and experience to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess. - Retest of approved components/containers/closures 21 CFR 211.87
Approved drug product containers are not retested or reexamined as appropriate for identity, strength, quality and purity after exposure to conditions that might have an adverse effect with subsequent approval or rejection by the quality control unit.
Registered with FDA for: manufacture.