Drug factory · FDA FEI 3004498861
MMS Norfolk, Inc.
521 Central Dr Ste 101-102, Virginia Beach, VA, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 20, 2013.
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 2013: 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 | MMS Norfolk, Inc, Rotech Healthcare Inc | 68623-123, 57439-005 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 20, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 20, 2013 inspection
- GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. - Component identification test 21 CFR 211.84(d)(2)
Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.
Registered with FDA for: manufacture.