I Shay passes inspection with no observations noted

I Shay Cosmetics, Hawthorne, CA, Irvine, CA, District

No 483 observations had been mentioned in an initial inspection of I Shay Cosmetics, Hawthorne, CA, but investigator John Gonzalez from the Irvine, CA, District Workplace reminded management to review all advice and GMPs concerning the manufacture of OTC drug solutions.

The EIR noted that I Shay is a customized manufacturer and personal labeler of cosmetics and own label distributor of industrial detergents. Items it manufactures feature lotions, skin creams, light detergents, dishwashing liquids, automobile wash products and solutions and shampoos, according to FDA data.

Gonzalez reviewed the subsequent methods, the EIR stated: compounding, sanitizing, packaging, delivery, receiving and laboratory. No objectionable situations were mentioned, though Gonzalez did recommend to President Mehdi Ehsan that he approve procedures, as none had approving signatures and dates.

"I also suggested he overview 21 CFR piece 210 and 211, as well as go to the FDA web-site earlier than earning any OTC drug items to make sure the firm can manufacture them according to GMPs," the report stated.

With regards to producing codes, Ehsan reported the firm "assigns a unique manufacturing code and a few-yr expiration date to finished items." Having said that, the FDAer noted, the corporation lacked a technique to assign the code and no balance studies have been on-hand for finished item. "Ehsan promised to build a process for assigning a incomparable code to all solutions and glance into the balance issue," the report stated.

Ehsan advised Gonzalez that he did not have a grievance-dealing with process "on the grounds that he has practically never had a complaint with any goods. Ehsan agreed with FDA's suggestion to produce written method, authored recall process and refer to 21 CFR 211 previously creating any OTC drug products.

In the course of the shut out meeting, Gonzalez also done the following suggestions:

* Rent a advisor prior to production OTC drugs

* Identify, segregate and discard unused, expired and old raw resources

* Update pest manage plan to deal with sorts of insecticides put into use and segregation

* Validate tools and

* Approve all methods.

The firm could not be attained for comment.

I Shay Cosmetics, Hawthorne, CA, two/5-nine/04, Doc. 109824M, $3 furthermore retrieval.