Inspections, Compliance, Enforcement, and Criminal Investigations
Bryant Ranch Prepack Inc. 4/8/10
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Los Angeles District
Irvine, CA 92612-2506
RETURN RECEIPT REQUESTED
April 8, 2010
Robert M. Mernick, President
Bryant Ranch Prepack
12623 Shennan Way, Suite A
North Hollywood, CA 91605
Dear Mr. Mernick:
From June 2 to June 11, 2009, the Food and Drug Administration (FDA) conducted an inspection of your facility located at 12623 Sherman Way, Suite A, North Hollywood, CA. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) regulations [Title 21 Code of Federal Regulations (CFR), Parts 210 and 211] in the manufacture of drug products. These CGMP deviations were listed on the Inspectional Observations (FDA483) form issued to you at the close of the inspection. These CGMP deviations cause your drug products to be adulterated within the meaning of section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)] of the Federal Food, Drug, and Cosmetic Act (the Act).
Our inspection revealed that your firm did not have a separated air-handling systems for the manufacture, processing, and packing of (b)(4) from those for other drug products for human use [21 CFR § 211.46(d)]. For example, the receiving, picking, (b)(4), and (b)(4) rooms shared a common air supply duct and air supply blower unit. The (b)(4) and (b)(4) rooms also shared a common air exhaust duct.
We acknowledge your August 10, 2009 response stating that as corrective actions our finn has separated the air handling systems for the repackaging of (b)(4)and (b)(4) products from the rest of the building, and separated the air supply units and air exhaust ducts. In addition, the (b)(4) room and (b)(4) room each now have their own separate air handling systems. However, we continue to have serious concerns about your firm's operations.
I. CGMP Violations
The CGMP deviations observed during the inspection include, but are not limited to, the following:
1. Your firm has not established separate or defined areas or such other control systems for your operations as are necessary to prevent contamination or mix-ups during the course of manufacturing and processing operations [21 CFR § 211.42(c)(5)]. In addition, your operations related to the manufacturing, processing, and packing of (b)(4) are not performed in facilities separate from those used for other drug products for human use [21 CFR § 211.42(d)], and people and materials are permitted to move freely between the (b)(4) and (b)(4) rooms, as well as the main facility.
2. When a reasonable possibility exists that a (b)(4) drug product has been exposed to cross-contamination with (b)(4), Current Good Manufacturing Practice regulations require testing of the (b)(4) drug products for the presence of (b)(4) [21 CFR § 211.176]. Because your firm lacks containment control procedures in the (b)(4) and (b)(4) rooms, there exists the possibility of cross contamination with other drug products. Your firm has not provided assurance through drug testing that (b)(4) drug products have not been exposed to cross-contamination with (b)(4).
3. Your firm does not have a written testing program designed to assess the stability characteristics of drug products in order to determine appropriate storage conditions and expiration dates [21 CFR § 211.166(a)]. For example, your fum lacked a written testing program calling for and failed to conduct stability studies to determine the stability of repackaged liquid drug products.
Although your firm has contacted an outside laboratory to conduct stability studies on repackaged liquids, your August 10, 2009 response does not specifically address any corrective actions that have been, or will be implemented.
II. Unapproved New Drugs
In addition to the CGMP violations stated above, you manufacture unapproved new drugs in violation of the Act. Based on labeling collected during the inspection of your facility, these unapproved new drugs include but are not limited to:
These products are drugs within the meaning of section 201(g) of the Act, [21 U.S.C. § 321(g)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases. Further, they are "new drugs" within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses. Under sections 301 (a) and (d) and 505(a) of the Act, [21 U.S.C. §§ 331 (a), (d) and 355(a)], a new drug may not be introduced into or delivered for introduction into intestate commerce unless an FDA-approve application is in effect for the drug. Based on our information, you do not have any FDA-approved applications on file for these drug products.
Additionally, the above products are misbranded because, as prescription drugs, adequate directions cannot be written for them so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for use as required under section 502(f)(1) of the Act, [21 U.S.C. § 352(f)(1)], and because the products lack required approved applications, they are not exempt from this requirement under 21 C.F.R. § 201.115. As noted above, the introduction or delivery for introduction into interstate commerce of these products without approved new drug applications violates Sections 301(a) and (d) of the Act [21 U.S.C. §§ 331(a) and (d)].
The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations and to implement global corrections to all of the facilities under your control.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending new drug applications listing your facility as a manufacturer, until the above violations are corrected. A reinspection may be necessary.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you no longer manufacture or market any of your drug products, your response should so indicate, including the reasons for, and the date on which, you ceased production.
Your reply should be sent to:
Daniel Cline, Acting Director
Los Angeles District Domestic Compliance Branch
U.S. Food & Drug Administration
Irvine, CA 92612
If you have any questions regarding this letter, please contact John J. Stamp, Compliance Officer, at (949) 608-4464.
Alonza E. Cruse
cc: Acting Branch Chief
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413