BMD Skincare
Form 483 issued March 5, 2019 · Canoga Park, California
- Inspection
- Feb 12 – Mar 5, 2019
- Investigators
- Diane R. Weidley· Uttaniti Limchumroon
- Observations
- 13
- Pages
- 12
- FEI number
- 3014199548
In short: On March 5, 2019, FDA issued a Form 483 with 13 observations to BMD Skincare in Canoga Park, California (FEI 3014199548) after an inspection that ran Feb 12 – Mar 5, 2019. The investigators were Diane R. Weidley and Uttaniti Limchumroon. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.84 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no written testing program designed to assess the stability…
- 02
Each lot of components is not withheld from use until the lot has been sampled, tested…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
There was a failure to handle and store components at all times in a…
This inspection in context
Diane R. Weidley
3 documents · 2019–2020
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in California.
The firmBMD Skincare history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BMD Skincare?
FDA listed 13 observations on this Form 483, mostly about laboratory controls, materials and quality system. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected BMD Skincare?
Diane R. Weidley and Uttaniti Limchumroon are named on this Form 483, for the inspection of Feb 12 – Mar 5, 2019. Each investigator has a profile showing what they cite most.
When was BMD Skincare inspected by FDA?
The inspection ran Feb 12 – Mar 5, 2019, and the Form 483 is dated March 5, 2019.
How do I get the full Form 483 for BMD Skincare?
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.