Dr. J SkinClinic, Inc.
Form 483 issued March 17, 2022 · Cerritos, California
- Inspection
- Feb 28 – Mar 17, 2022
- Investigators
- Hung H. Do· Wenzheng Zhang
- Observations
- 4
- Pages
- 6
- FEI number
- 3006185812
In short: On March 17, 2022, FDA issued a Form 483 with 4 observations to Dr. J SkinClinic, Inc. in Cerritos, California (FEI 3006185812) after an inspection that ran Feb 28 – Mar 17, 2022. The investigators were Hung H. Do and Wenzheng Zhang. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
Quality system and materials account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Drug product component testing is deficient in that at least one specific test to verify the…
- 02
Records associated with drug product components, production and distribution and within the retention period for such…
- 03
Results of stability testing are not used in determining appropriate storage…
- 04
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
This inspection in context
Hung H. Do
11 documents · 2021–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmDr. J SkinClinic, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84(d)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dr. J SkinClinic, Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system, materials and laboratory controls. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected Dr. J SkinClinic, Inc.?
Hung H. Do and Wenzheng Zhang are named on this Form 483, for the inspection of Feb 28 – Mar 17, 2022. Each investigator has a profile showing what they cite most.
When was Dr. J SkinClinic, Inc. inspected by FDA?
The inspection ran Feb 28 – Mar 17, 2022, and the Form 483 is dated March 17, 2022.
How do I get the full Form 483 for Dr. J SkinClinic, 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.