TSDR Pharmacy Inc. dba brandMD Skin Care
Form 483 issued March 28, 2017 · Chatsworth, California
- Inspection
- Mar 20 – Mar 28, 2017
- Investigator
- Liming Zhang
- Observations
- 6
- Pages
- 3
- FEI number
- 3009248035
In short: On March 28, 2017, FDA issued a Form 483 with 6 observations to TSDR Pharmacy Inc. dba brandMD Skin Care in Chatsworth, California (FEI 3009248035) after an inspection that ran Mar 20 – Mar 28, 2017. The investigator was Liming Zhang. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and production account for 4 of 6 observations.
Most cited: 21 CFR 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
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
There is no quality…
- 03
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are…
- 04
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Liming Zhang
19 documents · 2014–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmTSDR Pharmacy Inc. dba brandMD Skin Care history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at TSDR Pharmacy Inc. dba brandMD Skin Care?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, production and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected TSDR Pharmacy Inc. dba brandMD Skin Care?
Liming Zhang is named on this Form 483, for the inspection of Mar 20 – Mar 28, 2017. Each investigator has a profile showing what they cite most.
When was TSDR Pharmacy Inc. dba brandMD Skin Care inspected by FDA?
The inspection ran Mar 20 – Mar 28, 2017, and the Form 483 is dated March 28, 2017.
How do I get the full Form 483 for TSDR Pharmacy Inc. dba brandMD Skin Care?
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.