NeilMed Pharmaceuticals, Inc
Form 483 issued December 2, 2022 · Santa Rosa, California
- Inspection
- Nov 28 – Dec 2, 2022
- Investigator
- Dogbeda F. Mackenzie
- Observations
- 5
- Pages
- 7
- FEI number
- 3002998723
In short: On December 2, 2022, FDA issued a Form 483 with 5 observations to NeilMed Pharmaceuticals, Inc in Santa Rosa, California (FEI 3002998723) after an inspection that ran Nov 28 – Dec 2, 2022. The investigator was Dogbeda F. Mackenzie. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 04
Drug product component testing is deficient in that at least one specific test to verify the…
This inspection in context
Dogbeda F. Mackenzie
14 documents · 2021–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmNeilMed Pharmaceuticals, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at NeilMed Pharmaceuticals, Inc?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected NeilMed Pharmaceuticals, Inc?
Dogbeda F. Mackenzie is named on this Form 483, for the inspection of Nov 28 – Dec 2, 2022. Each investigator has a profile showing what they cite most.
When was NeilMed Pharmaceuticals, Inc inspected by FDA?
The inspection ran Nov 28 – Dec 2, 2022, and the Form 483 is dated December 2, 2022.
How do I get the full Form 483 for NeilMed Pharmaceuticals, Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.