Columbia Cosmetics Manufacturing, Inc.
Form 483 issued January 29, 2020 · San Leandro, California
- Inspection
- Jan 23 – Jan 29, 2020
- Investigator
- Scott N. Lim
- Observations
- 5
- Pages
- 5
- FEI number
- 2919184
In short: On January 29, 2020, FDA issued a Form 483 with 5 observations to Columbia Cosmetics Manufacturing, Inc. in San Leandro, California (FEI 2919184) after an inspection that ran Jan 23 – Jan 29, 2020. The investigator was Scott N. Lim. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not followed for evaluations done at least annually and including provisions for a…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate standards, sampling plans and…
- 03
Drug products failing to meet established standards, specifications and quality control…
- 04
Written records are not made of investigations into unexplained discrepancies and the failure of a batch…
This inspection in context
Scott N. Lim
14 documents · 2019–2026
Cites 211.165(a) (testing and release for distribution) more than any other section. Most of their documents are for sites in California.
The firmColumbia Cosmetics Manufacturing, 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 211.180(e)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Columbia Cosmetics Manufacturing, Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Columbia Cosmetics Manufacturing, Inc.?
Scott N. Lim is named on this Form 483, for the inspection of Jan 23 – Jan 29, 2020. Each investigator has a profile showing what they cite most.
When was Columbia Cosmetics Manufacturing, Inc. inspected by FDA?
The inspection ran Jan 23 – Jan 29, 2020, and the Form 483 is dated January 29, 2020.
How do I get the full Form 483 for Columbia Cosmetics Manufacturing, 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.